Biological indicator (BI) or chemical indicator (CI)? Which class or type? Indicator or integrator? The terminology of disinfection and sterilization protocols in dental offices may be confusing at times, but understanding the nuances is a critical part of safety.
According to the Organization for Safety, Asepsis and Prevention (OSAP), a common concern among dentists is whether Type 5 integrators are mandatory for use with biological indicators. According to CDC guidelines, BIs should be used weekly to verify functioning of sterilization cycles.
For clarification on Class 5 or now, Type 5 integrators, OSAP asked Eve Cuny, the director of Environmental Health and Safety and Assistant Professor in the Department of Pathology and Medicine at the University of the Pacific, Arthur A. Dugoni School of Dentistry. Cuny has consulted the Centers for Disease Control and Prevention (CDC) on issues related to safety and infection control in dentistry. She stated, “The AAMI/ANSI standard recommends BI at least weekly (and with any load of implantables) and a challenge pack with each load in addition to a CI [chemical indicator] in each pack. The challenge pack may consist of either a BI and a Type 5 CI or just a Class 5 CI.”
(AAMI is the Association for the Advancement of Medical Instrumentation and ANSI is the American National Standards Institute.)
Now that you know the necessity of a Type 5 integrator, it’s important to know what it does. A Type 5 integrator is designed to mimic the ability of a biological indicator at 3 separate and distinct points: time, temperature, and saturated steam. According to the infection control experts at SciCan, Type 5 integrators are the most accurate of all chemical indicators and contain a chemical ink, which reacts to all 3 sterilization parameters.
So, what is the key advantage of using a Type 5 indicator in conjunction with a biological indicator? The Type 5 indicator will monitor time, steam saturation and temperature without requiring incubation, which a biological indicator requires. Therefore, rather than waiting for the required BI to indicate whether the sterilization load was successful or not, the Type 5 integrator will provide an immediate read-out with wicking-style movement.
In terms of performance, is a Type 5 Integrator the equivalent of a biological indicator? Oversight and regulations in manufacturing ensure that it is. However, the CDC and the states still require the use of BIs, and the Type 5 integrators will give immediate feedback after every load, so there are no voids of assurance between BI tests and feedback from those tests. SciCan recently introduced its Sterilization Integrator Type 5 strips, which are FDA cleared as equivalent in performance to a biological indicator but not allowed to be a replacement for the traditional BIs. As an accessory to the manufacturer’s autoclaves, they have an operation from 121 to 135 degrees Celsius, approximately 250 to 275 degrees Fahrenheit. They are also ISO (International Organization for Standardization) compliant.
The before-and-after photos below show the wicking style movement of SciCan’s Sterilization Integrator Type 5 strips. The clear one is new, before use (left), while the strip with the blue line (right) is the successful one after running through a cycle in an autoclave. If you like what you’re seeing, contact SciCan to learn more about this product.
